Enforcement Report - Week of March 27, 2013

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Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085.
Quality Control (QC) materials have not exhibited low recovery of the same magnitude.
Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients, particularly samples with lower TACR values (e.g., less than 5 ng/mL [6.5 nmol/L]), may show a more appreciable difference due to the typical precision of each methodology.

Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.

Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.

Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.

The recall was initiated by Beckman Coulter because they are including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.

DePuy has received 9 complaints where the tabs on the reamer extension device were broken. It was determined to notify surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient while DePuy investigates the root cause. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.

The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.

A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.

Boston Scientific is conducting a recall on Cameron Health /Boston Scientific subcutaneous defibrillators (S-ICD® System). BS identified a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
No patient deaths or injuries have been reported as a result of this behavior; affected devices were replaced without the need for emergency medical care.

A recall has been initiated by Pan-O-Gold Baking Co. after they were notified by Dakota Specialty Milling of a potential foreign material (stainless steel wire from disintegrated sifter screen) risk to the rye flour Pan O Gold uses as an ingredient in all of their rye breads.